Kornimate/medical-research-clean huggingface dataset:
reducing transition drug risk

Conditions: Hospitalization

Summary: patient transfer between sites of care is regular practice during an episode of care in our current health care system. yet inter-site transfer is associated with lapses in care quality that adversely affect patient outcomes. a common iatrogenic harm precipitated at the time of transfer is harm from drug prescribing, or adverse drug events (ades). in this study we will evaluate a medication reconciliation tool developed to help providers make effective prescribing decisions at the time of transfer between va sites of care (improved prescribing after transfer (ipt)). we will evaluate the quantitative effectiveness of the tool in reducing transition drug risk and ades. we additionally will conduct focus group discussions and cognitive task analysis among end-users to better understand how providers make drug-prescribing decisions at the time of transfer and to assess factors influencing effective use of the tool.

this is a 2-phase study in which we will employ mixed quantitative and qualitative methods to conduct an evaluation of the ipt tool while improving our understanding of provider prescribing decisions at the time of patient transfer. in phase 1 we will conduct a 5-month controlled trial among all admissions to 2 units at j.j. peters (bronx) va medical center. we will compare ipt with usual care, and compare physician and pharmacist forms of ipt implementation with regard to, as primary outcome, transition drug risk, and, as secondary outcomes, ades, provider prescribing-decisions, and hospital utilization. in phase 2, which will run concurrently with phase 1, we will perform cognitive task analysis to examine providers' decision-making and to map ipt tool functions while providers interface with the tool, and perform focus group interviews with representative ipt users to identify factors that facilitate or hinder adoption. results of cognitive analysis and focus groups will be used to identify tool deficiencies to consider for redesign.

Eligibility criteria:
inclusion criteria: all patients who were admitted to the jj peters (bronx) va hospital general medical wards (units 7a and 7b) between 10/05-2/06 and stayed least 24 hours exclusion criteria: patients who were transferred to one of the study units wards (units 7a and 7b) from another jj peters (bronx) va hospital acute care unit (e.g., an intensive care unit), or who stayed in the hospital less than 24 hours

Keywords: clinical decision support systems continuity of patient care medication errors drug adverse effects
prevention of arthritis-related work disability

Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Osteoarthritis, Knee; Ankylosing Spondylitis

Summary: people with rheumatic disorders (arthritis) often have trouble keeping their jobs. this study will look at whether vocational rehabilitation (vr) will improve the ability of employed people with arthritis to keep their jobs. job retention vr services target key factors that increase the risk of job loss. they aim to modify jobs to reduce barriers caused by functional limitations and disease symptoms, future career planning, and establish a partnership with a vr counselor for ongoing help. we will conduct the study among patients with rheumatic disorders recruited in eastern massachusetts. we will give 120 study participants job retention services provided by vr counselors. we will give another 120 participants literature about employment- related resources. we will compare the outcomes of the two groups to evaluate the usefulness of job retention services in preventing job loss in people with rheumatic disorders.

job loss commonly occurs among people with rheumatic disorders. this study will determine whether vocational rehabilitation (vr) provided to employed people with rheumatic disorders will improve their ability to remain employed. vr is applied primarily to people who have already lost their jobs. however, using job retention vr services may prevent, or delay, the onset of employment work loss among people with rheumatic disorders. job retention vr services target important employment-loss risk factors. they do so by modifying jobs to reduce barriers posed by functional limitations and symptoms, promoting future career planning, and establishing an alliance with a vr counselor for ongoing assistance. the study is a randomized, controlled trial conducted among patients with rheumatic disorders recruited from the practices of rheumatologists in eastern massachusetts. we will randomly assign 120 study participants to receive job-retention services provided by vr counselors and 120 participants (controls) to receive literature about employment-related resources. we will assess intermediate outcome variables (self-efficacy, work limitations, and job accommodation-seeking behaviors) and the endpoint outcome variable, work instability (a measure that includes employment loss), immediately prior to the interventions and at 6-month intervals over a 24-month period after the interventions are carried out. we will compare the outcomes of the two groups to evaluate the usefulness of job retention services in forestalling work instability in this population.

Eligibility criteria:
inclusion criteria: * must currently be employed full or part time * must live in selected communities in eastern massachusetts exclusion criteria: * plans to move from area * plans to have joint replacement surgery in next 6 months * plans to retire or go on disability within next 2 years

Keywords: arthritis rheumatic disorders work-related disability vocational rehabilitation (vr) job retention services work limitations work instability
a longitudinal study of movement and participation in life activities of young children with cerebral palsy in taiwan

Conditions: Cerebral Palsy

Summary: this study investigates the longitudinal course of developmental patterns in movement and participation in life activities (mpla) of young children with cerebral palsy (cp) in taiwan. additionally, the predictors in the initial stage in determining the final developmental patterns in movement and participation in life activities mpla of these children will be identified.

most researches investigated the longitudinal study of functions in adolescent or adult with cp, however, few researches investigate these functions in children with cp. knowledge of these developmental patterns in movement and participation in life activities mpla may be helpful in understanding, anticipating, and managing the problems of these children. we hypothesize that the course of developmental patterns in mpla of young children with cp evolves with their age. this study investigates the longitudinal course of developmental patterns in mpla of young children with cp in taiwan. this study includes a validity and reliability study and a prospective longitudinal study of young children with cp over one-year. this study will be executed in 4 years and a validity and reliability study in the first year.

Eligibility criteria:
inclusion criteria: * diagnosis of cp exclusion criteria: * presence of a progressive neurological disorder or a severe concurrent illness or disease not typically associated with cp, such as traumatic brain injury or active pneumonia
study of eo-3021 in adult patients with solid tumors likely to express cldn18.2

Conditions: Pancreas Neoplasm; Stomach Neoplasm; Gastrointestinal Neoplasms; Digestive System Neoplasm; Neoplasms by Site; Neoplasms

Summary: this study is an open-label, international, multi-center, phase 1 study in adult patients with solid tumors likely to express cldn18.2.


Eligibility criteria:
key inclusion criteria: * availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible) * select advanced or metastatic solid tumor that is likely to express cldn18.2 such as gastric/gej, pancreatic and esophageal cancer * ≥ 18 years of age * ecog performance status (ps) 0 or 1 at screening * progressed on or after standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy * have at least one measurable extra-cranial lesion as defined by recist v1.1 * adequate organ function * life expectancy \> 12 weeks * ability to understand the nature of this study, comply with protocol requirements, and give written informed consent * willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following study completion key exclusion criteria: * pregnant or breastfeeding * symptomatic or untreated brain metastases * have previously received cldn18.2 antibody drug conjugates (adcs) or any adc containing an auristatin payload (prior monoclonal antibody against cldn18.2 may be eligible) * have peripheral neuropathy grade ≥2 * have history of non-infectious pneumonitis/interstitial lung disease * have diagnosis of another malignancy, or history of systemic treatment for invasive cancer within last 3 years. note: patients with stage i cancer who have received definitive local treatment and are considered unlikely to recur are eligible. diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or noninvasive tumor does not affect eligibility * have active ocular surface disease at baseline (based on screening ophthalmic examination) * have serious concurrent illness or clinically relevant active bacterial, fungal or viral infection * have previous hypersensitivity to any known components of eo-3021 or history of severe infusion reaction or hypersensitivity (ctcae grade 3 or higher) with monoclonal antibody treatment * clinically significant cardiac disease, including but not limited to symptomatic congestive heart failure, unstable angina, acute myocardial infarction within 6 months of planned first dose, or unstable cardiac arrhythmia requiring therapy (including torsades de pointes) * have history of allogenic hematopoietic stem cell transplantation or solid organ transplantation with ongoing systemic immunosuppressive therapy * patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator

Keywords: gastric cancer gastroesophageal junction (gej) adenocarcinoma esophageal cancer pancreatic cancer
ionm during radical prostatectomy

Conditions: Prostate Cancer

Summary: at present, the preferred treatment for patients with prostate cancer is still radical prostatectomy. postoperative patients often face some complications, the most common complications include urinary incontinence and erectile dysfunction. urinary incontinence is caused by intraoperative injury of urinary control nerves or muscles. erectile dysfunction is related to intraoperative injury of nerves that control erection. therefore, intraoperative nerve preservation is a key measure to reduce postoperative complications, especially to prevent erectile dysfunction. this study intends to improve the nerve-sparing radical prostatectomy by monitoring the nerve during radical prostatectomy, locating the cavernous nerve and other related nerves, in order to reduce the incidence of postoperative complications such as erectile dysfunction.


Eligibility criteria:
inclusion criteria: - 1: prostate cancer patients undergoing surgical treatment in our hospital 2: understand the content of this study, actively provide complete and true medical history and examination data, and be willing to cooperate with postoperative interviewers. 3: voluntarily participate in the study and sign the treatment document within the ethical framework. exclusion criteria: * 1: histopathology showed that the patient did not have prostate cancer 2: use a cardiac pacemaker or other electromechanical prosthesis device 3: suffering from a serious neurological disease, mental illness or other illness that may be life-threatening within two years

Keywords: prostate cancer intraoperative neuromonitoring urinary incontinence erectile dysfunction
nebulizer intervention for minority children with asthma

Conditions: Asthma

Summary: to determine if teaching parents and children to identify the child's asthma symptoms early and if teaching the appropriate use of a nebulizer will result in a decrease in emergency department visits.

nebulizer use in young children is common with prevalence of 33-71% in children under age 12 years. nebulizers are used primarily to administer saba medications, (i.e., albuterol) and some anti-inflammatory medications (i.e., budesonide, cromolyn). parents may prefer nebulizer delivery due to the inability of young children to coordinate respiration with aerosol delivery and many parents lack confidence in administering metered-dose inhaler (mdi) medications to young children. physician preference for nebulizer administration of asthma medications is low, but is favored due to direct medication delivery to the respiratory system despite studies indicating mdis with spacers are as effective as nebulizers in delivering asthma medications to young children. although national guidelines recommend a nebulizer with mask for children 2 years or younger most asthma educational programs lack specific content addressing appropriate nebulizer technique including when and what symptoms to treat at home, optimal length of a nebulized medication session, prevention of saba overuse and appropriate cleaning and maintenance of the device. because the overuse of home nebulizer saba medications has been associated with fatal asthma, instruction and supervision of nebulized rescue medication delivery in addition to appropriate preventive medication use may reduce asthma morbidity and mortality . the current study was conducted to determine the effectiveness of a home-based nebulizer educational intervention (nei) for young children with asthma. the intervention was designed to teach early symptom recognition, appropriate medication use and nebulizer technique for home treatment of acute asthma episodes. study outcomes included symptom frequency, activity limitation, emergency department (ed) visits and hospitalizations, appropriate asthma medication use and nebulizer practice. we hypothesized that children receiving the nei would demonstrate improvement in appropriate nebulizer and asthma medication use and decreased asthma symptoms, activity limitation, ed visits and hospitalizations.

Eligibility criteria:
inclusion criteria: * physician diagnosed asthma, use of nebulizer in past 30 days, wheezing or cough symptoms at least weekly during the past 30 days. exclusion criteria: * participation in another asthma study or having other respiratory illness such as cystic fibrosis, bpd
subjective evaluation of a commercially marketed contact lens amongst a subset of the contact lens wearing population

Conditions: Myopia

Summary: the purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.


Eligibility criteria:
inclusion criteria: * habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly. * wears lenses at least 5 days per week and at least 12 hours per day. * removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights. * reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always". * able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses. * has acceptable or optimal fit for each eye at the dispense of each pair of study lenses. * other protocol-defined inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks prior to enrollment. * pre-existing ocular irritation that would preclude contact lens fitting. * currently enrolled in any clinical trial. * any use of medications for which contact lens wear could be contraindicated as determined by the investigator. * currently sleeping in contact lenses for more than 6 consecutive nights. * currently wearing daily disposable contact lenses and certain protocol-specified lens brands. * other protocol-defined inclusion/exclusion criteria may apply.
phase i/iia study of fixfc in hemophilia b patients

Conditions: Hemophilia B

Summary: the primary objective of the study is to assess safety of fixfc at doses ranging from 1 to 100 iu/kg.

this study was previously posted by syntonix pharmaceuticals, inc. in january, 2007, sponsorship of the trial was transferred to biogen idec. in february, 2017, sponsorship of the trial was transferred to bioverativ.

Eligibility criteria:
key inclusion criteria: 1. are previously treated (ptps) with severe (\<2 iu/dl endogenous fix level) hemophilia b and at least 150 prior documented exposure days to other fix products. 2. have no prior history of or currently detectable inhibitor defined as \> 0.6 bethesda units by the local lab. a family history of inhibitors will not exclude the patient. 3. no prior history of an allergic reaction or anaphylaxis associated with any fix or ivig administration. 4. no concurrent autoimmune disease. 5. at least 7 days since their last dose of fix (wash-out period). 6. certain laboratory testing criteria and other protocol-defined criteria may apply. 7. hiv negative or if hiv positive with a cd4 count ≥ 200 cells/mm3. hiv patients are allowed to receive protease inhibitors per the discretion of the investigator. key exclusion criteria: 1. presence of a major bleeding episode on day 1 of study. 2. any coagulation disorder in addition to hemophilia b. 3. a patient currently on a dose and regimen of fix that would preclude participation in the study due to possible increased risk of bleeding because of the requirement to withhold treatment during the study period. 4. a positive d-dimer at screening. 5. documented history of liver cirrhosis. 6. positive for hbsag and/or positive for hepatitis c antibody, and/or hiv positive with an alt or ast greater than 5 times upper limit of normal. 7. certain prior illnesses and other protocol-defined criteria. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: hemophilia b severe, previously treated patients
construction of the evaluation system of limb blood circulation after fracture of limbs in children

Conditions: Blood Circulation Disorder

Summary: this study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. the investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.

the investigator will retrospect the data of operative patients with limb fracture in pediatric orthopedics unit of shanghai xinhua hospital in 2016 to collect the basic information about this kind of patient, including age, gender, kind of fracture, temperature and color of skin, swell, artery pulse, laboratory test indicators, method of fixation, and the usage of mannitol. then, combining the professionals' suggestions, the investigator will use multi-factor regression to identify the independent risk factors of blood circulation disorder. according to the independent risk factors, the early-warning model of blood circulation disorder will be built, and the rating scale as well. finally, the critical value of blood circulation disorder after limb fracture will be set by receiver operating characteristic curve.

Eligibility criteria:
inclusion criteria: * age from 0 to 14 years; * children with limb fractures diagnosed by x-ray film; * the surgical method is open reduction and wire-pin fixation or steel plate internal fixation; * children with postoperative plaster fixation; * children whose guardian signed informed written consent. exclusion criteria: * children with nerve damage which have caused dysfunction such as sensory and motor; * children with fracture in other parts or organic diseases.

Keywords: limb fracture limb blood circulation early-warning model children
performance of a new glucose meter system

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.


Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes * age 18 years or older * routinely performs blood glucose self testing at home, at least once per day * able to speak, read, and understand english. * is willing to complete all study procedures exclusion criteria: * currently pregnant * hemophilia or any other bleeding disorder * taking prescription anticoagulants or has clotting problems that may prolong bleeding. taking aspirin daily is not excluded * subject employee of competitive medical device company * cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
effect of fasting time before cesarean section on neonatal blood glucose in pregnant women with gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus

Summary: objective: to observe the effect of different fasting time on neonatal blood glucose in pregnant women with gestational diabetes mellitus (gdm). methods: 122 pregnant women with gestational diabetes mellitus were selected from september 2018 to september 2020 in xx hospital for regular prenatal examination, matching of pregnancy and delivery times, and undergoing elective lower uterine cesarean section to terminate pregnancy. the pregnant women were divided into 5 groups according to their fasting time before operation and whether they were given rehydration on the same day before operation, there were 27 cases in group b (fasting time 12.75 ± 0.48 hours, no rehydration before operation), 20 cases in group c (fasting time 15.65 ± 0.52 hours, no rehydration before operation), 24 cases in group d (fasting time 12.75 ± 0.48 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation), 24 cases in group e (fasting time 15.65 ± 0.52 hours, intravenous drip of 5% glucose sodium chloride 500ml at 8:00 on the day of operation). the blood glucose of pregnant women within half an hour before operation, the blood glucose of newborns after delivery and the incidence of neonatal hypoglycemia were observed and recorded.


Eligibility criteria:
inclusion criteria: (1) the pregnant woman is born at term and has a single child; (2) regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as gestational diabetes mellitus; (3) pregnant women with body mass index (bmi) \< 35kg/㎡; (4) all the operations were performed electively, and epidural anesthesia was used as the surgical anesthesia. exclusion criteria: (1) pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension; (2) insufficiency of vital organ function or complicated tumor; (3) pregnant women with other pregnancy complications besides gdm, such as preeclampsia, etc.; (4) the operation method is classical cesarean section or pregnant women with postpartum hemorrhage;

Keywords: gestational diabetes mellitus cesarean section preoperative fasting neonatal blood glucose